Clinical Efficacy and Safety of Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Resectable Gastric Cancer

301Qiaoz

This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.

2023-10-01

2025-04-30

2025-07-30

Recruiting

Early phase I

80

Inclusion Criteria: * The subjects voluntarily joined this study and signed an informed consent form * Locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology as HER-2 negative (cT2-4N+M0 Phase II-III) * The primary lesion can be surgically removed, and the patient is willing to receive surgical treatment * There are measurable solid tumors (efficacy evaluation standard: RECIST 1.1) * Tumor evaluation should be conducted through CT scanning or MRI within 28 days before treatment * ECOG score 0-1 * Life expectancy ≥ 12 months. Exclusion Criteria: * Preoperative imaging examination indicates distant or peritoneal metastasis in patients * Subjects with any known active autoimmune disease * Serious cardiovascular disease * The serum of the subjects tested positive for HIV * Active hepatitis B (HbsAg positive and HBV-DNA ≥ 10 \^ 3copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral treatment at the same time) * Known subjects with previous allergies to macromolecular protein formulations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy * Have a history of alcohol, drug, or substance abuse * Individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-02-29